Panadol Cold & Sinus
PACKAGELEAFLET:TNFORMATTONFORTHEUSER
Panadol Cold and Sinus 500 mg / 30 mg Film Coated Tablets Paracetamol and Pseudoephedrine Hydrochloride
Please read right through this leaflet before you start using this medicine.
This medicine is available without prescription, but you still need to use Panadol Cold and Sinus carefully to get the best results from it.
• Keep this leaflet. You may need to read it again.
• If you have any questions, or there is something you do not understand, ask your pharmacist.
Tn this leaflet:
1. What Panadol Cold and Sinus does
2. Check before you take Panadol Cold and Sinus
3. How to take Panadol Cold and Sinus
4. Possible side effects
5. How to store Panadol Cold and Sinus
6. Further information
What Panadol Cold and Sinus does
Panadol Cold and Sinus is used for the relief of nasal congestion when combined with fever and/or pain such as sore throat, sinus pain or headache in the common cold or flu. The medicine contains two active ingredients. Paracetamol is a painkiller and reduces your temperature when you have a fever. Pseudoephedrine hydrochloride is a decongestant which unblocks your nose and sinuses helping you breathe more easily without drowsiness.
2. Check before you take Panadol Cold and Sinus
(X symbol) Do not take Panadol Cold and Sinus:
• If you have ever had an allergic reaction to paracetamol, pseudoephedrine hydrochloride or other sympathomimetics (such as decongestants, appetite suppressants or stimulant drugs called amfetamines), or any of the other ingredients (listed in Section 6).
• If you have high blood pressure, overactive thyroid gland, enlarged prostate, heart problems, glaucoma (excessive pressure inside your eyes).
• If you have kidney problems, unless your doctor tells you to.
• If you have taken monoamine oxidase inhibitors (MAOIs), usually prescribed for depression, in the last two weeks.
• If you are taking the drug moclobemide for depression, beta-blockers for high blood pressure, the antibiotics furazolidone or linezolid, appetite suppressants, or stimulant drugs called amfetamines (sometimes used to treat attention deficit disorders or excessive sleepiness).
• For more than 5 days unless your doctor tells you to.
• If you are under 12 years.
Do not take with any other paracetamol containing products.
Do not take with any other flu, cold or decongestant product.
(! symbol) Driving and using machines:
This product can cause dizziness as a side effect which could affect your ability to drive or use machines.
(! symbol) Ask your doctor before you take this medicine:
If you are due to undergo general anaesthesia, or have liver disease, including alcoholic liver disease, diabetes, irregular heart beat or phaeochromacytoma (a tumour near the kidney).
(! symbol) If you are taking other medicines:
Talk to your doctor or pharmacist before taking these tablets if you are taking any prescribed medicines; particularly:
• anticoagulants (used to thin the blood, e.g. warfarin);
• metoclopramide or domperidone (for nausea [feeling sick] or vomiting [being sick]);
• cholestyramine (to lower blood cholesterol);
• medicines for high blood pressure;
• medicines for depression (tricyclic antidepressants);
• sodium bicarbonate (used to treat indigestion and certain kidney conditions).
(! symbol) Pregnancy and breastfeeding:
Do not take Panadol Cold and Sinus if you are pregnant or breastfeeding.
3. How to take Panadol Cold and Sinus
(^ symbol) Take the tablets with a glass of water.
Adults (including the elderly):
Swallow 2 tablets up to 3 times daily, every 4 hours as needed. Do not take more than 6 tablets (3 doses) in 24 hours.
Adolescents aged 12 to 18 years:
Give 1 to 2 tablets every 4 hours as needed.
Do not give more than 6 tablets in 24 hours.
(! symbol)
Do not take more than every 4 hours.
Do not take for more than 5 days.
Do not take more than the recommended dose.
If you take too many tablets:
Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.
If your symptoms persist, see your doctor or pharmacist.
Possible Side Effects
Like all medicines Panadol Cold and Sinus can have side effects, but not everybody gets them: Stop taking this medicine and seek immediate medical attention if you experience:
• Sudden severe headache. This is very rare (occurring in fewer than 1 in every 10,000 patients treated).
• Allergic reactions such as skin rash or itching, sometimes with breathing problems (or a hissing sound when you breathe) or swelling of the lips, tongue, throat or face. These reactions are rare (occurring in fewer than 1 in every 1,000 patients treated).
• Breathing problems, especially if you have experienced a similar reaction with aspirin or non-steroidal anti-inflammatories. These are very rare (occurring in fewer than 1 in 10,000 patients treated).
• Skin rash or peeling, or mouth ulcers. These effects are very rare (occurring in fewer than 1 in 10,000 patients treated).
• Unexplained bruising or bleeding, or infections such as sore throat - this may be a sign of very rare changes in the blood. These occur in fewer than 1 in 10,000 patients treated.
• Difficulty in passing urine. This is uncommon (occurring in fewer than 1 in every 100 patients treated) and is more likely to occur if you have an enlarged prostate gland.
The following side effects may occur. Tell your doctor or pharmacist if you get them.
• Nausea [feeling sick], vomiting [being sick], dry mouth, sleep disturbance, nervousness and dizziness. These are common side effects, (occurring in fewer than 1 in every 10 patients treated). 1
• High blood pressure and hallucinations are rare side effects, (occurring in fewer than 1 in every 1,000 patients treated).
This product may have side effects that you would not notice yourself. These include changes in some liver test results.
If you do get any side effects, even those not mentioned in this leaflet, tell your doctor or pharmacist.
5. How to Store Panadol Cold and Sinus
Keep out of the reach and sight of children.
Do not take the medicine after the “EXP” date shown on the blister and outer carton. Do not use the medicine if you notice the tablets are soft.
Do not store above 25°C.
6. Further Information
Active ingredients. Each tablet contains Paracetamol 500 mg and Pseudoephedrine Hydrochloride 30 mg.
Other ingredients. Cellulose microcrystalline (E460), silica, colloidal anhydrous (E551), stearic acid (E570), magnesium stearate (E572), starch pregelatinised, povidone, crospovidone, croscarmellose sodium (E468), hypromellose (E464), macrogol, carnuba wax (E903), indigo carmine (E132).
What Panadol Cold and Sinus looks like and contents of the pack
The tablets are blue and white and marked with a figure “2” in a circle. Packs contain 2, 5, 6, 10, 12, 16, 18, 24, 30 or 321 tablets.
Marketing Authorisation Holder and Manufacturer
The marketing authorisation holder is Omega Pharma Ltd, 1st Floor, 32 Vauxhall, Bridge Road, LONDON, SW1V 2SA, United Kingdom.
All enquiries should be sent to above address.
The manufacturer is Famar S.A., Anthoussa, Athens, Greece.
This leaflet was last revised in December 2012
Panadol and Solpa-Sinus are registered trademarks of the GlaxoSmithKline group of companies.
This medicinal product is authorised in the Member States of the EEA under the following names:
Ireland Solpa-Sinus Film-coated Tablets Paracetamol 500mg Pseudoephedrine Hydrochloride 30mg
UK Panadol Cold and Sinus 500 mg/ 30 mg Film-coated Tablets
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Notes:
* Delete as appropriate.
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Rapid or irregular heart rate, agitation and restlessness. These are uncommon side effects (occurring in fewer than 1 in every 100 patients treated).